This phase II trial studies how well halofuginone hydrobromide works in treating patients with human immunodeficiency virus (HIV)-related Kaposi's sarcoma. Halofuginone hydrobromide ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

Response rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

McNemar's chi-square test will be used to compare vehicle control and halofuginone with respect to response rates.

Safety of topical halofuginone as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 30 days after completion of treatment ] [ Designated as safety issue: Yes ]

McNemar's chi-square test will be used to compare the two treatments with respect to the incidence of specific adverse events.

Secondary Outcome Measures:

Change in MMP-2 and collagen type I levels [ Time Frame: From baseline to 4 weeks ] [ Designated as safety issue: No ]

Change in MMP-2 and collagen type I levels [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]

Changes from baseline in MMP-2 and Collagen type I for halofuginone and vehicle control lesions will be compared using the Wilcoxon rank sum test.

Relationship of CD4, CD8, HIV viral load and HHV-8 viral load on response [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

ARM I: Patients apply topical halofuginone hydrobromide ointment to each of 6 lesions twice a day for 12 weeks.

ARM II: Patients apply topical placebo ointment to each of 6 lesions twice a day for 12 weeks.

Patients with stable or responding disease in either or both groups of treated lesions (halofuginone hydrobromide ointment or placebo ointment) may receive open-label treatment with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks as above in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 1 month.

Eligibility

Ages Eligible for Study:

16 Years and older (Child, Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Biopsy-proven Kaposi's sarcoma with at least 14 cutaneous lesions, 12 of which are measurable in two dimensions and can serve as marker lesions; each of the 14 lesions must measure a minimum of 0.5 cm in diameter, so that a 4 mm punch biopsy will be entirely composed of Kaposi's sarcoma

Serologic documentation of HIV infection by any of the Food and Drug Administration (FDA) approved tests

Total bilirubin should be =< 1.5 x upper limit of normal (ULN); if, however, the elevated bilirubin is felt to be secondary to indinavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is =< 3.5 mg/dl provided that the direct bilirubin is normal

Ability and willingness to give informed consent; patients who are younger than 18 years of age will require the consent of a parent or guardian.

All women of childbearing potential must have a negative serum b human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued

Patients must, in the opinion of the investigator, be capable of complying with the protocol

Patients receiving antiretroviral therapy must be on a stable regimen for at least 12 weeks prior to study entry without showing evidence of ongoing Kaposi's sarcoma (KS) regression (ie, less than 25% decrease in the size, number or nodularity of KS lesions in the opinion of the investigator); patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND; concurrent treatment with highly active antiretroviral therapy should be strongly encouraged, in accordance with DHHS guidelines (http://www.aids-ed.org/pdfs/adult_2-4-02.pdf) but will not be required for participation

Exclusion Criteria:

Concurrent, acute, active, untreated opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment

Previous local therapy of any KS-indicator lesion within 60 days unless the lesion has clearly progressed since treatment

Corticosteroid treatment, other than replacement doses

Use of investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols

Pregnant or breast feeding females are excluded from participation in this study since the effects of halofuginone on an unborn or young child are unknown and may potentially be toxic

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064142